Stability after freezing and thawing of solutions of mitomycin C in plastic minibags for intravesical use
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Solutions of 0.6 mg/ml mitomycin C (Mutamycin®) in NaCl solution 0.9% in plastic minibags for intravesical use were stored at −20°C and −30°C and thawed by microwave radiation. Both unbuffered solutions and solutions buffered to approximately pH 7·5 were investigated. Concentrations were measured with HPLC. During freezing and storage at −20°C sometimes crystallization of mitomycin C occurred. However, both buffered and unbuffered solutions could be frozen at −30°C during at least four weeks and subsequently thawed without loss of content. Unbuffered mitomycin C solutions could be refrozen at −30°C for another four weeks. Also buffered and unbuffered solutions of another brand of mitomycin C (Mitomycin-C Kyowa®) could be frozen at −30°C during four weeks without significant deterioration.
Key wordsDrug stability Mitomycin C Freezing Quantitative analysis Sterilization Thawing, microwave radiation
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